Race and Ethnic Representation in Crohn's Disease Trials of Biologic and Small Molecule Medications: A Systematic Review and Meta-analysis.

BACKGROUND AND AIMS: Randomised controlled trials historically under-represent marginalised racial and ethnic populations. As incidence and prevalence of Crohn's disease in these groups rise, it is important to characterise their inclusion in randomised controlled trials on first-line and pipe-line medications. METHODS: PubMed was searched systematically for randomised controlled trials of biologic and small molecule inhibitor [SMI] medications, with a primary outcome related to efficacy following PRISMA guidelines. We used descriptive statistics to summarise demographic variables and meta-regression analyses to estimate temporal trends in racial inclusion. RESULTS: More than a half of trials did not report any racial/ethnic demographics [53.7%] and several reported racial demographics for only one race [20.9%]. When racial data were reported, Whites made up 90.2% of participants. Percentages of Black, Asian, Native American/Pacific Islander, and participants considered 'Other' averaged 2.9%, 11.6%, 0.5%, and 1.6% out of the total sample sizes of 3901, 3742, 828 and 4027, respectively. Proportional representation of White participants decreased over time [p <0.01] and proportional representation of Asian participants increased over time [p = 0.047]. In ordinal logistic regression, mean year of trial enrolment significantly increased the number of racial groups reported [p <0.001]. CONCLUSIONS: Half of published randomised controlled trials in Crohn's disease contain no racial or ethnic demographics, and the remaining often only have limited inclusion of Black, Native American/Pacific Islander, and Hispanic patients. Further work should characterise representation in observational and prospective trials. Researchers should work to: 1] increase reporting of racial and ethnic demographics; and 2] improve recruitment and retention of marginalised populations.

Cooking with the Community: Addressing Food Insecurity Through Equipment Provision and Professional Instruction.

Introduction: Food insecurity is a common problem with many associated negative downstream health impacts. Despite government sponsored and private supports, many individuals struggle with making healthy, nutritious meals. Penn State's Cooking with the Community program was constructed with the objective of providing cooking equipment and instructions to increase knowledge of healthy cooking techniques and consumption of under-utilized food pantry ingredients. Methods: Four cooking demonstrations were held over an 8-month study period in 2021 designed to educate participants on under-utilized and seasonally available ingredients. Each demonstration was professionally led by a chef who taught cooking skills and the use of different equipment, which were subsequently gifted to the participants. Participants were surveyed before and after each demonstration to assess cooking perceptions and comfort using Likert scales. Final analysis was completed in 2022 using mixed effects models to analyze changes between pre- and post-demonstration. Results: There were 34 total participants. Statistically significant improvements were seen in confidence in cooking (mean increase=0.5; SD=0.2; p=0.031; 95% CI=0.1, 1.0), preparation of a simple recipe (mean increase=0.6; SD=0.2; p=0.013; 95% CI=0.1, 1.0), and cooking new foods (mean increase=0.6; SD=0.3; p=0.026; 95% CI=0.1, 1.1). Conclusions: Cooking with the Community provides valuable information on how cooking confidence may be boosted within vulnerable populations by providing cooking equipment and professional instructions on its use.

Characterization of Traumatic Injury During the Early COVID-19 Pandemic: Results From a National Healthcare Database.

OBJECTIVE: To characterize traumatic injury patterns after stay-at-home orders were implemented in the United States in response to the coronavirus disease 2019 (COVID-19). METHODS: A retrospective review of a convenience sample of patients from a national healthcare research database (TriNetX) was conducted from April 1, 2020, to June 30, 2020. Inclusion criteria included all patients with documentation of both injury pattern and mechanism of injury. A comparison was made to a matched pre-pandemic timeframe. Changes in percentage and rate ratio (RR) with a 95% confidence interval were reported. RRs were calculated using Poisson regression analysis. RESULTS:  A total of 238,661 patients in the control and 178,224 patients in the study cohorts were analyzed. Significant increases in assaults (RR: 1.17, 95% CI: 1.14, 1.20) and bicycle accidents (RR: 1.07, 95% CI: 1.04, 1.11) were noted. There was a relative increase in patients who were male (+1.78%) and white (+2.01%). More injuries were alcohol-related (+0.76%) and occurred at home (+0.79%). A decrease in motor vehicle accidents (-1.17%), foot and ankle injuries (-1.63%), and injuries occurring at sporting events (-0.54%) was noted. CONCLUSIONS: Changes in injury patterns were observed during the study period. During future crises, particular public health and injury prevention resources may be required to address assaults, substance abuse, and home safety.

SARS-CoV-2 vaccine effectiveness against infection, symptomatic and severe COVID-19: a systematic review and meta-analysis.

BACKGROUND: The temporal evolution of SARS-CoV-2 vaccine efficacy and effectiveness (VE) against infection, symptomatic, and severe COVID-19 is incompletely defined. The temporal evolution of VE could be dependent on age, vaccine types, variants of the virus, and geographic region. We aimed to conduct a systematic review and meta-analysis of the duration of VE against SARS-CoV-2 infection, symptomatic COVID-19 and severe COVID-19. METHODS: MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, the World Health Organization Global Literature on Coronavirus Disease, and CoronaCentral databases were searched and studies were selected. Independent reviewers selected randomized controlled trials and cohort studies with the outcome of interest. Independent reviewers extracted data, and assessed the risk of bias. Meta-analysis was performed with the DerSimonian-Laird random-effects model with Hartung-Knapp-Sidik-Jonkman variance correction. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach was used to assess certainty (quality) of the evidence. Primary outcomes included VE as a function of time against SARS-CoV-2 infection, symptomatic and severe COVID-19. RESULTS: Eighteen studies were included representing nearly 7 million individuals. VE against all SARS-CoV-2 infections declined from 83% in the first month after completion of the original vaccination series to 22% at 5 months or longer. Similarly, VE against symptomatic COVID-19 declined from 94% in the first month after vaccination to 64% by the fourth month. VE against severe COVID-19 for all ages was high overall, with the level being 90% (95% CI, 87-92%) at five months or longer after being fully vaccinated. VE against severe COVID-19 was lower in individuals ≥ 65 years and those who received Ad26.COV2.S. CONCLUSIONS: VE against SARS-CoV-2 infection and symptomatic COVID-19 waned over time but protection remained high against severe COVID-19. These data can be used to inform public health decisions around the need for booster vaccination.

Comparison of Barrett and Emmetropia Verifying Optical Toric Calculators.

PURPOSE: The purpose of this study was to compare the Barrett (BTC) and Emmetropia Verifying Optical (EVO) Toric Calculators' performance with regards to prediction of residual post-operative astigmatism after cataract surgery. METHODS: This was a secondary analysis of de-identified data that was collected as part of a prospective multicenter clinical trial in which 109 eyes from 109 patients were implanted with a monofocal toric intraocular lens (IOL). Post-operative biometry was used to calculate the predicted post-operative residual astigmatism for each eye using the two different calculators. The vector difference between the actual and predicted residual astigmatism was calculated. RESULTS: The mean absolute astigmatism prediction errors were 0.59 ± 0.38 D and 0.59 ± 0.36 D for the BTC and EVO calculators, respectively (p = 0.98). The centroid of the prediction errors were 0.18 D @ 89° ± 0.68 D and 0.20 D @ 89° ± 0.66 D, respectively (p = 0.21). The proportion of eyes in which the astigmatism prediction error was ≤0.5 D was 50% for BTC and 46% for EVO (p = 0.28). The proportion of eyes in which the post-operative astigmatism orientation was correctly predicted as being against-the-rule, with-the-rule, or oblique was 81% for BTC and 77% for EVO (p = 0.15). CONCLUSION: The Barrett and Emmetropia Verifying Optical Toric Calculators had similar performance with regards to their astigmatism prediction accuracy.

Short-term and Long-term Rates of Postacute Sequelae of SARS-CoV-2 Infection: A Systematic Review.

Importance: Short-term and long-term persistent postacute sequelae of COVID-19 (PASC) have not been systematically evaluated. The incidence and evolution of PASC are dependent on time from infection, organ systems and tissue affected, vaccination status, variant of the virus, and geographic region. Objective: To estimate organ system-specific frequency and evolution of PASC. Evidence Review: PubMed (MEDLINE), Scopus, the World Health Organization Global Literature on Coronavirus Disease, and CoronaCentral databases were searched from December 2019 through March 2021. A total of 2100 studies were identified from databases and through cited references. Studies providing data on PASC in children and adults were included. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for abstracting data were followed and performed independently by 2 reviewers. Quality was assessed using the Newcastle-Ottawa Scale for cohort studies. The main outcome was frequency of PASC diagnosed by (1) laboratory investigation, (2) radiologic pathology, and (3) clinical signs and symptoms. PASC were classified by organ system, ie, neurologic; cardiovascular; respiratory; digestive; dermatologic; and ear, nose, and throat as well as mental health, constitutional symptoms, and functional mobility. Findings: From a total of 2100 studies identified, 57 studies with 250 351 survivors of COVID-19 met inclusion criteria. The mean (SD) age of survivors was 54.4 (8.9) years, 140 196 (56%) were male, and 197 777 (79%) were hospitalized during acute COVID-19. High-income countries contributed 45 studies (79%). The median (IQR) proportion of COVID-19 survivors experiencing at least 1 PASC was 54.0% (45.0%-69.0%; 13 studies) at 1 month (short-term), 55.0% (34.8%-65.5%; 38 studies) at 2 to 5 months (intermediate-term), and 54.0% (31.0%-67.0%; 9 studies) at 6 or more months (long-term). Most prevalent pulmonary sequelae, neurologic disorders, mental health disorders, functional mobility impairments, and general and constitutional symptoms were chest imaging abnormality (median [IQR], 62.2% [45.8%-76.5%]), difficulty concentrating (median [IQR], 23.8% [20.4%-25.9%]), generalized anxiety disorder (median [IQR], 29.6% [14.0%-44.0%]), general functional impairments (median [IQR], 44.0% [23.4%-62.6%]), and fatigue or muscle weakness (median [IQR], 37.5% [25.4%-54.5%]), respectively. Other frequently reported symptoms included cardiac, dermatologic, digestive, and ear, nose, and throat disorders. Conclusions and Relevance: In this systematic review, more than half of COVID-19 survivors experienced PASC 6 months after recovery. The most common PASC involved functional mobility impairments, pulmonary abnormalities, and mental health disorders. These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries.

Global optical coherence tomography measures for detecting the progression of glaucoma have fundamental flaws.

OBJECTIVE: To understand the problems involved in using global OCT measures for detecting progression in early glaucoma. SUBJECTS/METHODS: Eyes from 76 patients and 28 healthy controls (HC) had a least two OCT scans at least 1 year apart. To determine the 95% confidence intervals (CI), 151 eyes (49 HC and 102 patients) had at least two scans within 6 months. All eyes had 24-2 mean deviation ≥-6dB. The average (global) thicknesses of the circumpapillary retinal nerve fibre layer (cRNFL), GONH, and of the retinal ganglion cell layer plus inner plexiform layer (RGCLP), Gmac, were calculated. Using quantile regression, the 95% CI intervals were determined. Eyes outside the CIs were classified as "progressors." For a reference standard (RS), four experts evaluated OCT and VF information. RESULTS: Compared to the RS, 31 of the 76 (40.8%) patient eyes were identified as progressors (RS-P), and 45 patient, and all 28 HC, eyes as nonprogressors (RS-NP). The metrics missed (false negative, FN) 15 (48%) (GONH) and 9 (29%) (Gmac) of the 31 RS-P. Further, GONH and/or Gmac falsely identified (false positive, FP) 10 (22.2%) of 45 patient RS-NP eyes and 7 (25%) of the 28 HC eyes as progressing. Post-hoc analysis identified three reasons (segmentation, centring, and local damage) for these errors. CONCLUSIONS: Global metrics lead to FPs and FNs because of problems inherent in OCT scanning (segmentation and centring), and to FNs because they can miss local damage. These problems are difficult, if not impossible, to correct, and raise concerns about the advisability of using GONH and Gmac for detecting progression.

Reasons why OCT Global Circumpapillary Retinal Nerve Fiber Layer Thickness is a Poor Measure of Glaucomatous Progression.

Purpose: To assess the effects of local defects, segmentation errors, and improper image alignment on the performance of the commonly used optical coherence tomography (OCT) measure of progression, that is the change in global (average) circumpapillary retinal nerve fiber layer (cpRNFL) thickness (ΔG). Methods: One hundred fifty eyes suspected of, or with, early glaucoma had OCT circle and cube scans obtained using eye tracking on two occasions at least 1 year apart. Statistical progression was defined by fixed values of ΔG (3-8 um) and quantile regression. For a reference standard, four authors identified 30 eyes as "likely progressed," and 61 eyes that "likely had not progressed" based on OCT reports from both baseline and follow-up tests. Results: A ΔG criterion of 4 um had the best accuracy: 77%, with 5 false positive (8.2%) and 16 false negative (53%). A post hoc analysis of circular b-scans and OCT probability maps of these eyes indicated that segmentation errors and local progression accounted for most of these mistakes. Segmentation errors, although less common, were also present in true positives and true negatives. Conclusions: Local defects and segmentation errors are the primary reasons for the poor performance of cpRNFL thickness G metric. Because these problems are difficult, if not impossible, to eliminate, the G metric should not be relied on in isolation for detecting glaucomatous progression. Translational Relevance: Local defects and segmentation errors are easily identified by viewing OCT circumpapillary images, which should be part of the standard protocol for detecting glaucomatous progression.

An Automated Method for Assessing Topographical Structure-Function Agreement in Abnormal Glaucomatous Regions.

Purpose: To develop an automated/objective method for topographically comparing abnormal regions on optical coherence tomography (OCT) and visual field (VF) tests of eyes with early glaucoma. Methods: A custom R program was developed that allows for both visualization and automatic assessment of the topographical agreement between functional (24-2 and/or 10-2 VF) and structural (widefield OCT retinal nerve fiber layer and/or retinal ganglion cell layer) deviation/probability maps. It was optimized using information from 98 eyes: 53 diagnosed as "definitely glaucoma" (DG) and 45 recruited as healthy (H) controls. Different pairs of abnormal VF (P <1%, <2%, <5%) and abnormal OCT (P <5%, <10%, <15%) criteria were evaluated. The percentages of abnormal structure-abnormal function (aS-aF) agreement found in DG eyes and nonagreement found in H eyes were used to define the optimal criteria and number of aS-aF locations for the detection of aS-aF agreement. Results: A criterion of two aS-aF locations with "OCT <10% and VF <5%" on VF pattern deviation (PD) probability and OCT deviation/probability maps yielded high overall agreement (92%) with high aS-aF agreement for the DG eyes (89%) and high aS-aF nonagreement for the H eyes (95%). Total deviation probability maps achieved slightly lower performance than PD maps. Conclusions: The method described here can automatically and objectively evaluate aS-aF agreement with a direct comparison of abnormal regions of function and structure. Translational Relevance: As glaucoma diagnosis often involves assessing structure-function agreement, this technique can overcome subjectivity in this assessment.

Association of Macular Visual Field Measurements With Glaucoma Staging Systems.

Importance: Macular function is important for daily activities but is underestimated when tested with 24-2 visual fields, which are often used to classify glaucoma severity. Objective: To test the hypothesis that current glaucoma staging systems underestimate glaucoma severity by not detecting macular damage. Design, Setting, and Participants: This cross-sectional study was carried out in a glaucoma referral practice. The eyes of participants with manifest glaucoma and 24-2 mean deviation (MD) better than -6 dB were included. All participants were tested with 24-2, 10-2 visual fields, and spectral-domain optical coherence tomography of the optic disc and macula. Exposures: Macular damage was based on the topographic agreement between visual field results and retinal ganglion cell plus inner plexiform layer probability plots. Classifications from the Hodapp-Parrish-Anderson (HPA), visual field index (VFI), and Brusini staging systems were examined and compared with visual field and spectral-domain optical coherence tomography results. Main Outcomes and Measures: The association between the presence of macular damage and glaucoma severity scores. Results: Fifty-seven eyes of 57 participants were included; 33 participants (57%) were women, and 43 (75%) were white. Their mean (SD) age was 57 (14) years. Forty-eight of the eyes (84% [95% CI, 72%-92%]) had macular damage by the study definition. These had a 24-2 MD mean (SD) of -2.5 (1.8); corresponding results for the 10-2 MD were -3.0 (2.4) dB and for the VFI were 94.2% (4.5%). The HPA system classified 70% (95% CI, 55%-83%) of eyes with macular damage as having early defects; the VFI system classified 81% (95% CI, 67%-91%) of eyes with macular damage as having early defects, and the Brusini system 68% (95% CI, 53%-81%). Conclusions and Relevance: These findings suggest that current glaucoma staging systems based on 24-2 (or 30-2) visual fields underestimate disease severity and the presence of macular damage. If these results are confirmed and generalizable to other participants, new systems using macular measures (from 10-2 and spectral-domain optical coherence tomography results) might improve staging of glaucoma severity.